Document from CIS Legislation database © 2003-2018 SojuzPravoInform LLC

DECISION OF BOARD OF THE EUROASIAN ECONOMIC COMMISSION

of September 7, 2018 No. 151

About approval of the Management on creation of the regulating document on quality of medicine

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, articles 4 and 13 of the Agreement on the single principles and rules of drug circulation within Euroasian economic soyuzaot on December 23, 2014 the Board of the Euroasian economic commission solved:

1. Approve the enclosed Management on creation of the regulating document on quality of medicine.

2. This Decision becomes effective after 6 months from the date of its official publication.

Chairman of Board of the Euroasian economic commission

T. Sargsyan

Approved by the Decision of Board of the Euroasian economic commission of September 7, 2018 No. 151

Management on creation of the regulating document on quality of medicine

I. General provisions

1. The present manual is developed taking into account appendix No. 3 to the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Euroasian economic commission of November 3, 2016 No. 78 (further – Rules) and establishes procedure for creation of the regulating document on quality of medicine (further – the regulating document on quality).

2. The present manual extends to medicines irrespective of their origin (chemical, biological, vegetable, etc.).

3. The regulating document on quality establishes requirements to medicine quality control (contains the specification and the description of techniques of testing or references to them, and also the corresponding eligibility criterions of indicators of quality, etc.) based on the carried-out medicine expertize, affirms authorized body of state member of the Eurasian Economic Union (further respectively – state member, the Union) in case of registration of medicine and is intended for quality control of medicine during the post-registration period in the territories of state members.

4. The regulating document on quality is constituted only concerning medicine.

Concerning active pharmaceutical substance creation of the regulating document on quality is not required.

5. The regulating document on quality contains the data on quality of medicine included in Sections 3.2.P. 1, 3.2.P.5. 1, 3.2.P.5. 2, 3.2.P.7 and 3.2.P.8.1 of the module 3 registration files of medicine (appendix No. 4 to Rules) and used by control laboratories of state members,

not having access to the module 3, for control of quality of medicines. The data containing in the module 3 registration files of medicine have paramount value. The data containing in the regulating document on quality cannot contradict the data containing in the module 3 registration files of medicine.

6. The regulating document on quality is constituted taking into account the instructions provided by appendix No. 3 to Rules.

7. Specifications on the active pharmaceutical substances received by chemical synthesis, and containing them medicines are constituted according to requirements according to appendix No. 1.

8. The present manual is applied to the following dosage forms:

firm dosage forms for intake;

liquid dosage forms for intake;

parenteral dosage forms (big and small amounts).

The procedure for creation of the regulating document on quality and specifications to the specified dosage forms can be applied to other dosage forms.

9. General requirements to creation of specifications on medicines and active pharmaceutical substances of biological origin are established in Chapter 6 of Rules of carrying out researches of the biological medicines of the Eurasian Economic Union approved by the Decision of Council of the Euroasian economic commission of November 3, 2016 No. 89.

10. General requirements to creation of specifications on medicinal vegetable drugs are established in the management at the choice of tests and eligibility criterions for creation of specifications on drugs from medicinal vegetable raw materials approved by the Euroasian economic commission.

11. Requirements to creation of specifications on the medicines of separate types and active pharmaceutical substances which are their part depending on their dosage form or properties of active ingredient are determined by the relevant acts entering the right of the Union.

12. Concerning the medicines specified in

Items 8-10 of the present manual, and also radio pharmaceutical drugs the present manual contains only requirements to execution of the regulating document on quality.

II. Structure of the regulating document on quality

13. The structure of the regulating document on quality shall correspond to appendix No. 3 to Rules and keep 8 Sections in the following order:

a) the title page in form according to appendix No. 2;

b) composition of medicine;

c) specification;

d) description of techniques of testing;

e) description of packaging;

e) marking;

g) storage conditions;

h) period of validity (storages).

14. Indicators of quality and the regulated regulations are given according to the specification of the producer for the end of period of validity (storage). In the presence of the same indicator of quality in specifications on release and for the end of period of validity (storage) the regulated regulations for such indicator are given in the regulating document on quality according to the specification of the producer for the end of period of validity (storage).

1. Title page

15. In the form of the title page of the regulating document on quality are specified:

Full text available with active License only!

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

Effectively work with search system

Database include more 38000 documents. You can find needed documents using search system. For effective work you can mix any on documents parameters: country, documents type, date range, teams or tags.

Get help

If you cannot find the required document, or you do not know where to begin, go to Help section.

In this section, we’ve tried to describe in detail the features and capabilities of the system, as well as the most effective techniques for working with the database.

You also may open the section Frequently asked questions. This section provides answers to questions set by users.

Search engine created by SojuzPravoInform LLC. UI/UX design by Intelliants.